At-home self-testing companies should disclose the risks associated with testing.

Testing laboratories must have a robust procedure for notifying users of abnormal results.

Patients need an explanation of their particular findings.

Historically, medical tests have been available only through healthcare providers who communicate results to the patient. This is changing quickly, however.

“At-home self-testing disrupts this provider-centric model by providing access to medical information and test results without necessarily involving a knowledgeable professional in the process,” says Margaret R. McLean, PhD, associate director of the Markkula Center for Applied Ethics at Santa Clara (CA) University.

McLean says desire for knowledge, privacy, and control of information are the main drivers of at-home medical self-testing. “As a former clinical pathologist, I am not wildly enthusiastic about direct-to-consumer medical testing,” adds McLean. “However, it is a logical step in our do-it-yourself, just-in-time, instant-access culture.”

At-home self-testing can promote autonomy and a proactive role for the patient in healthcare and wellness, McLean acknowledges. Accuracy and test interpretation, however, “are the bedrock of medical testing,” she cautions. Patients need an explanation of their particular findings, such as whether a high glucose level means they have diabetes.

“There is further concern for patients receiving false or misleading information in a murky regulatory environment,” says McLean. She says the following practices are needed:

At-home self-testing companies should disclose the risks associated with testing. These include rates of false negatives and false positives, psychological risk, and, in the case of genetic testing in particular, the potential risk to family members of information disclosure.

Testing laboratories must have a robust procedure for notifying users that a result is abnormal, and encouraging users to see their primary care provider and/or providing a referral and access to needed follow-up services.

“As with other non-emergency medical interventions, at-home self-testing requires informed consent,” says McLean. This means that essential information must be given to the consumer in a way that is clear and understandable. “This mitigates against health decisions being based on incomplete and/or misunderstood test results,” explains McLean.

More research needed

Healthcare providers have established methods for testing patients and follow recommendations from organizations such as the Centers for Disease Control and Prevention on how often people should test and what to do if they test positive, notes Sean Young, PhD, executive director of the University of California Institute for Prediction Technology and assistant professor of family medicine at University of California, Los Angeles.

“But it’s different with self-testing,” says Young. “It’s new. We don’t have years of experience and research to know how people feel when they test, and what they do after they test.”

It’s unknown how individuals will feel psychologically, whether they will seek help, or whether they will take medication as needed. Still, says Young, “the benefits of self-testing are clear.” He gives the example of people at high risk for HIV who are not testing through traditional methods. For this group, says Young, self-testing kits provide a way to increase identification, potentially decreasing transmission.

Young says more research is needed on the effectiveness of self-testing. “Our research team has shown that groups at high-risk for HIV are willing to use self-tests,” he reports. “But we don’t have enough information on whether these tests prevent new infections.”

A primary ethical concern with self-testing is that important health decisions will be based on misunderstood data. “I worry that many of those who will engage in at-home self-testing are the ‘worried well’ who will order unnecessary and inappropriate tests, potentially leading to more testing that further burdens the system,” says McLean.

Kenneth W. Goodman, PhD, director of the University of Miami Miller School of Medicine’s Institute for Bioethics and Health Policy, says more data is needed on risks of self-testing, especially regarding the consequences of errors and the utility of pre- and post-test counseling. “Such data will help us strike the correct balance between autonomy and paternalism,” he says.

Many home tests are commonly done, such as blood sugar, sexually transmitted infections, and cholesterol, notes Goodman, “and to no ill effect.”

Goodman says that in some ways, self-testing is not unlike representing oneself in court. “If you go into it with eyes wide open, know and freely accept the risks of something going wrong, then you should not be forbidden from doing so. But others will generally do it better,” he says.

Goodman says one often-overlooked ethical issue is the consequences that widespread self-testing could have on public health. Tests in clinics and hospitals are easily analyzed for patterns that reflect the health of communities.

“By taking all these tests offline, we might lose a valuable source of information that has been found to be precious for public health,” says Goodman.

Nonetheless, as technology steadily puts assays in the hands of ordinary people, says Goodman, “we must take a more accommodating stance, albeit with adequate regulation.”